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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

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MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE Back to Search Results
Model Number 8637-40
Device Problems Infusion or Flow Problem (2964); Protective Measures Problem (3015)
Patient Problem Muscular Rigidity (1968)
Event Date 03/31/2022
Event Type  malfunction  
Manufacturer Narrative
Other relevant device(s) are: product id: 8781, serial/lot #: (b)(4), ubd: 28-oct-2022, udi#: (b)(4), implanted: (b)(6) 2021, product type: catheter. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a foreign healthcare provider (hcp) via a manufacturer's representative (rep) regarding a patient (b)(6) 2022, it was reported that the patient was experiencing a reduced effect of the pump and spasticity. The patient underwent an x-ray and it was noted that the hcp could not see the first part of the catheter, though the rest of the catheter was visible. The sideport or catheter access port (cap) was accessed with puncture going very smoothly, but the hcp was unable to withdraw any fluid other than "half a drop of clear moisture". It was noted that the spasticity was not too disruptive and the patient's condition was "not too good" so the hcp was going to refrain from performing a revision. Additional information was received from a foreign healthcare provider (hcp) via a manufacturer's representative (rep) on 2022-apr-12. It was reported that the cause of the inability to aspirate the catheter and the issue of the catheter not being radiopaque was not determined. It was confirmed that the health condition causing the hcp to delay the revision procedure was unrelated to the device or therapy. The issue was not considered resolved.
 
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Brand NameSYNCHROMED II
Type of DevicePUMP, INFUSION, IMPLANTED, PROGRAMMABLE
Manufacturer (Section D)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer (Section G)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer Contact
glen belmer
7000 central avenue ne rcw215
minneapolis, MN 55432
6122713209
MDR Report Key14092112
MDR Text Key289209219
Report Number3004209178-2022-04640
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
Reporter Country CodeBE
PMA/PMN Number
P860004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 04/12/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/13/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/28/2022
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/31/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/13/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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